FDA.reportPublic FDA data

Galantamine

Product NDC
71335-2766
11-digit product format
713352766
Labeler code
71335
Product ID
71335-2766_29de3c5e-581d-4ab9-b0eb-2218eff2e821
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090957
Marketing category
ANDA
Marketing start
2011-03-29
Substance
GALANTAMINE HYDROBROMIDE
Active strength
4 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Galantamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALANTAMINE HYDROBROMIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMJ4PTD2VVW
Rxcui310436

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f780b87f-43f1-2d63-f0ea-2c214058238eProduct name220160831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2766-1Galantamine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310436galantamine HBr 4 MG Oral TabletPSN261889d3-41c8-4655-98f7-41317778e7a11
310436galantamine 4 MG Oral TabletSCD261889d3-41c8-4655-98f7-41317778e7a11
310436galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral TabletSY261889d3-41c8-4655-98f7-41317778e7a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2766-17133527660160 TABLET, FILM COATED in 1 BOTTLE (71335-2766-1) 2025-10-03NoNoHistorical